Registration Dossier

Administrative data

Description of key information

The test material is not acute toxic. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

This substance does not show any evidence of toxicity via the oral route of exposure in animals when tested in accordance with FHSA 16 CFR 1500.3 (1977). The rat oral LD50 is greater than 10 ml/kg bw. No mortality occurred. No signs of systemic toxicity, or behavioral changes were reported during the study, and no abnormalities were noted at necropsy. In a second study this substance shows evidence of toxicity when tested in accordance with OECD 401. The rat oral LD50is estimated at approximately 2000 mg/kg.No gross pathology was found in surviving animals.No specific organ toxicity is evident.

The dermal route for acute toxicity is appropriate if the physicochemical properties suggest there is potential for a significant rate of absorption through the skin. The scientific literature regarding dermal toxicity states that for those substances with a log Kow greater than 5 there is very limited potential for dermal absorption (e.g,. 10% absorption) (Annals of Occupatinoal Hygiene, 47(8):641-652, 2003). The test material has a Log Kow greater than 7.1 (small portion < 0.3) thereby demonstrating that it has very limited dermal absorption potential. In contrast, oral absorption can be relatively fast due to contact surface areas in the GI tract resulting in a peak concentration in the body, and GI tract has been regarded as the route resulting in higher bioavailability. For the test material, dosing via oral route represents the worst case scenario for assessing acute exposure, and acute dermal toxicity end point satisfied by acute oral toxicity results (LD50>2000 mg/kg).

 

Integrated testing strategies for acute toxicity state that determination of the most likely route of exposure needs to take into account not only how the substance is manufactured and handled, including engineering controls and risk management measures, but also the physicochemical properties of the substance. The test material is intended for use as an antiwear agent for grease, gear oil lubricants and farm tractor lubricants. Gear oils and manual transmission fluids are typically used in fill for life applications therefore down-stream exposure will be low; the application in grease products is predicted to have low exposure potential. Also the test materialhas very low volatility. The vapour pressure has been determined to be 0.032 Pa at 25oC, thus there is minimal potential for any inhalation of gases or vapors. ECHA guidance states that for the inhalation route no testing is required if the vapor pressure is very low (< 0.1 Pa at 20oC) (see ECHA Guidance R.7 as well as OECD GD 39). Therefore inhalative acute toxicity is of no relevance.

Based on a weight of evidence analysis of the manufacturing and handling, physicochemical properties, and available toxicological information, the substance was excluded from the need for acute dermal and inhalation toxicity testing as it is not scientifically necessary, the available information is sufficient for an adequate hazard characterization, and the exposure to the substance is adequately controlled.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is required for acute toxicity.